Zara Extended Chin Implant
FDA 510(k) K910457 · Byron Medical
510(k) numberK910457
Submission
- Device name
- Zara Extended Chin Implant
- Applicant
- Byron Medical
Tucson, AZ, US - Received
- February 4, 1991
- Decision date
- February 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWP – Prosthesis, Chin, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K934179 | Disposable Bag DecanterKPE · Traditional | 05/23/1994SE |
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Questions and answers
When was Zara Extended Chin Implant cleared by the FDA?
Zara Extended Chin Implant (K910457) received a 510(k) decision of Substantially Equivalent on February 19, 1991, 15 days after the submission was received.
What is the product code of K910457?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.